AQT90 FLEX NTproBNP (N-terminal Pro-brain Natriuretic Peptide) 2 Test Kit - Clinical Evaluation Study Protocol - China

NCT ID: NCT07208877

Last Updated: 2025-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-31

Study Completion Date

2026-01-31

Brief Summary

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To validate the NTproBNP2 Test Kit by using the test results of the predicate device as a reference. It will be demonstrated that the investigational product (NTproBNP2 Test Kit) and the predicate are equivalent. Subsequently, it will be demonstrated that the investigational product can be used in clinical testing.

Detailed Description

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Conditions

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Diagnostic Tests

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

Samples that meet all the following criteria will be eligible for enrollment:

1. Samples from subjects with current or previous signs and/or symptoms of heart failure, or diagnosed heart failure.
2. Sample-related information is available, including a unique and traceable number, sample type, age, gender, date of sample collection, and clinical diagnosis, etc..
3. The sample volume is adequate, no less than 2 mL of whole blood.
4. The sample collection shall meet the informed consent waiver requirements of the ethics committee.

Exclusion Criteria

Samples that meet any of the following criteria will be excluded:

1. Duplicate collection of samples from the same subject.
2. Samples that do not meet the collection, handling, and storage requirements outlined in the product's instructions for use.
3. Samples that are suspected of being poor quality, i.e. samples suspected of containing clots, visible hemolysis or lipids, or samples suspected of being contaminated with possible interfering substances.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radiometer Medical ApS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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DC-092723

Identifier Type: -

Identifier Source: org_study_id

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